Phase 3
N=60
A Study of Safety and the Local Anesthetic Effect of AG-920 Ophthalmic Solution in a Pediatric Population
Anesthesia, Local
Bottom Line
View on ClinicalTrials.gov: NCT05325853 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: The Proportion of Participants in Which an Eye Exam Was Able to be Performed — 30; 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AG-920 (Drug); Proparacaine Ophthalmic (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- American Genomics, LLC
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Participants in Which an Eye Exam Was Able to be Performed |
30; 30 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
0; 0 | — |
Summary
A Phase 3, randomized, active-controlled, study in pediatric subjects. It is designed to evaluate the safety and anesthetic efficacy of one dose of AG-920 ophthalmic solution compared to Proparacaine Hydrochloride Ophthalmic Solution.
Eligibility Criteria
Inclusion Criteria
- Pre-pubescent with no childbearing potential
- Capable of undergoing an eye exam
- Subject's legally appointed and authorized representative willing to sign and date an informed consent form (ICF) and, where appropriate, the subject willing to sign an assent form prior to any study-related procedures being performed.
- Parent/legal guardian and subject are willing and able to follow instructions and can be present for the required study visits and Follow-up Phone Call for the duration of the study.
- Have a healthy, normal cornea.
Exclusion Criteria
- Have participated in an investigational study (drug or device) within the past 30 days.
- Have a known contraindication to local anesthetics.
- Children with known autism spectrum disorders or known to have heightened sensitivity.
- Corneal pathology that would make the corneal sensitivity lower/higher or make the test hard to perform or interpret.
- Have low visual acuity
- Manifest nystagmus
- Have had ocular surgery or general surgery within the past 45 days.
- Have had an intravitreal injection in either eye within 14 days of randomization.
- Have ocular surface disease.
Data sourced from ClinicalTrials.gov (NCT05325853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.